NCT02817347

A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea

A Randomized, Double-blind, Multicenter, Phase2 Trial to Evaluate the Safety and Efficacy of YH1177 or YH1177-D Otic Soultion in Patients With Otitis Media and Otorrhea

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

In patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability, and the proportion of patients with cessation of otorrhea after ear-drop administration of YH1177 or YH1177-D for 14 days and therefore to determine the optimal clinical dose.

Detailed description

Patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation. Screening should be completed within 7 days prior to randomization. patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation at randomization visit will be randomized in one of the defined groups.

Conditions

• Otitis Media
• Otorrhea

Interventions

Type	Name	Description
DRUG	piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%
DRUG	piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%
DRUG	piperacillin 2% + tazobactam 0.25%
DRUG	piperacillin 4% + tazobactam 0.5%
DRUG	piperacillin 8% + tazobactam 1.0%

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-04-13
• Completion: 2017-04-13
• First posted: 2016-06-29
• Last updated: 2022-01-13

Locations

1 site across 1 country: South Korea